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Changes in the user fee program as a result of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) are detailed in a new FDA final guidance issued on Friday. Read More
The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database. Read More
Over the past week, the FDA issued several guidance documents — including a final guidance on developing nicotine replacement therapy drug products, a final guidance on quality risk management and a draft guidance on decentralized clinical trials for drugs, biological products and devices. Read More
In a Senate hearing on reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act (PAHPA), FDA Commissioner Robert Califf reiterated the agency’s call for better data and more supply chain notification authority to prevent future drug and medical device shortages. Read More
Despite more than half of treated patients developing adverse reactions, Eli Lilly will seek a traditional full approval for donanemab after topline phase 3 data showed that the antiamyloid antibody prevented further cognitive decline in 47 percent of early-stage Alzheimer’s patients and slowed decline by up to 36 percent on two other scales. Read More
To reflect the more current organizational structure and processes in its Office of Generic Drugs (OGD), the FDA has published a manual of policies and procedures (MAPPs) update focused on bioequivalence (BE) studies with clinical endpoints. Read More
GSK has crossed the finish line with Arexvy (RSVPreF3-AS01E), the first respiratory syncytial virus (RSV) vaccine to win FDA approval for individuals age 60 years and older, but approval of Pfizer’s RSV candidate, Abrysvo (RSVpreF), may not be far behind. Read More
Lupin has been hit with a 10-observation Form 483 following an inspection of its Madhya Pradesh, India, drug manufacturing facility that revealed a failure to adequately handle out-of-specification results of batches that ended up on the U.S. market and remained there without “adequate justification.” Read More
The FDA has sent Champaklal Maganlal Homeo Pharmacy, located in Gujarat, India, a warning letter citing contamination issues after the agency’s Nov. 15, 2022, request for product testing records. Read More
The FDA handed APS Pharmacy a warning letter following the company’s response to a Form 483 that failed to address observations of the company’s compounding drug products using ineligible bulk drug substances. Read More
The FDA has issued a warning letter to Omega Packaging Corp. for failure to test active pharmaceutical ingredients for impurities and a lack of response from the company to this and other issues raised in a recent inspection. Read More